QC-Micro QMS Specialist (Sterile Injectables)

Medivant Healthcare; United States; Remote; USD 120,000 - 150,000; Full time

Job summary

Medivant Healthcare is seeking a Quality Management Systems leader for its Quality Control Microbiology department. You will oversee QMS activities, investigations, CAPAs, and documentation to ensure regulatory alignment and timely closure of deviations.

You will also manage data integrity, method transfer/validation, SOPs, audits, and training, while driving continuous improvement and cross-functional collaboration across the organization.

Qualifications

• Requires solid understanding of QMS within a quality-controlled lab.
• Experience with microbiological QC in sterile injectable environments.
• Proven ability to review data for regulatory compliance.
• Excellent documentation and record-keeping.
• Strong problem-solving and communication skills.

Responsibilities

• Oversee and perform all QMS activities for the Quality Control Microbiology department.
• Conduct investigations related to OOS/OOT, environmental monitoring deviations, and sterility failures.
• Identify root causes and implement CAPAs.
• Ensure timely closure of deviations and maintain documentation.
• Lead preparation, review, and approval of QMS documentation including change controls, risk assessments, and quality records.
• Prepare and review documentation for microbiological QC processes.
• Review and verify data from microbiological analysis for raw materials, in-process samples, finished products, and environmental monitoring.
• Ensure data integrity and cGMP compliance.
• Approve Certificates of Analysis (CoA) for final product release.
• Review quarterly trends and collaborate on corrective actions.
• Oversee method transfer and validation; ensure methods are validated.
• Review and approve SOPs and validation protocols.
• Oversee environmental monitoring and sterility programs.
• Prepare for internal and external audits; address gaps; support regulatory inspections.
• Training and competency assessment for QC microbiology personnel.
• Lead continuous improvement initiatives.
• Maintain regulatory compliance documentation.

Skills

QMS knowledge

Regulatory compliance

cGMP experience

Documentation skills

Analytical thinking

Cross-functional collaboration

Environmental monitoring

Audit readiness

Training & competency

Job description

Key Responsibility:

Quality Management System (QMS) Activities:

• Oversee and perform all Quality Management System (QMS) activities for the Quality Control Microbiology department.
• Conduct and review investigations related to microbiological laboratory OOS/OOT, environmental monitoring deviations, and sterility failures.
• Identify root causes and recommend corrective and preventive actions (CAPAs).
• Ensure timely closure of laboratory deviations and maintain thorough documentation.
• Lead the preparation, review, and approval of QMS documentation, including change controls, risk assessments, and quality records.
• Perform and oversee the preparation and review of documentation related to microbiological QC processes, ensuring alignment with regulatory and internal standards

Microbiology Data Review:

• Review and verify data from microbiological analysis for raw materials, in-process samples, finished products, and environmental monitoring.
• Ensure data integrity and compliance with cGMP and regulatory standards.
• Approve microbiological Certificates of Analysis (CoA) for final product release

Trend Analysis and Reporting:

• Review and analyze quarterly trends for microbiological results, environmental monitoring, sterility tests, and deviation reports.
• Collaborate with QC teams to implement corrective measures based on trend analysis

Method Transfer and Validation:

• Oversee method transfer activities between manufacturing sites or contract laboratories.
• Ensure microbiological methods are validated and meet required specifications.
• Review and approve method validation and verification reports

Standard Operating Procedures (SOPs) and Protocol Review:

• Review and approve laboratory SOPs to ensure compliance with regulatory guidelines and internal quality standards.
• Evaluate and approve method validation protocols and reports for microbiological analysis.
• Ensure the accuracy and execution of environmental monitoring and sterility study protocols and reports.
• Oversee the preparation and review of SOPs and protocols related to QMS activities

Environmental Monitoring and Sterility Oversight

• Monitor and oversee the execution of environmental monitoring and sterility programs.
• Ensure environmental monitoring and sterility programs align with regulatory guidelines and product specifications

Audit Preparation and Compliance

• Prepare the Quality Control Microbiology department for internal and external audits (US FDA, state FDA, customer audits, etc.).
• Conduct pre-audit checks to assess laboratory readiness and compliance.Address audit observations and ensure timely closure of identified gaps.
• Support regulatory inspections by providing necessary documentation and explanations.
• Training and Competency Assessment:
• Develop and conduct training programs for QC microbiology personnel on SOPs, regulatory guidelines, and good laboratory practices (GLP).
• Assess and monitor the competency of microbiology analysts

Continuous Improvement Initiatives:

• Lead initiatives to improve microbiological QC processes and enhance efficiency.
• Participate in cross-functional teams to drive quality improvement projects

Regulatory Compliance and Documentation:

• Ensure microbiological QC laboratory operations comply with cGMP, US FDA, and other regulatory requirements.
• Maintain comprehensive and organized QC microbiology documentation, including laboratory notebooks, logbooks, and validation reports.
• Prepare and review documentation to ensure regulatory compliance and accuracy

Mandatory Requirements:

• Valid B1/B2 Visa for the USA.
• Willingness to travel for work, including international travel to the USA and other regions as required.
• Have to work as per US timings when working remotely.

Key Skills and Competencies:

• In-depth knowledge of Quality Control in sterile injectable microbiology processes.
• Experience of laboratory oversight for microbiology analysis.
• Strong analytical and problem-solving skills.
• Effective communication and documentation skills.
• Ability to manage cross-functional teams and prioritize tasks.
• Proficiency in QMS tools and software.